Ischemic Heart DiseaseDIAST-CMDNCT05058833
Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function
An observational study of Ischemic Heart Disease and Microvascular Coronary Artery Disease, run by Samsung Medical Center at 4 sites in 2 countries.
Trial summary
The DIAST-CMD registry (Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function) is prospective registry which enrolled patients who underwent echocardiography, cnically-indicated invasive coronary angiography and comprehensive physiologic assessments including fractional flow reserve… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Heart Disease, Microvascular Coronary Artery Disease, Diastolic Dysfunction
- What is being tested?
- Echocardiography and Coronary flow reserve and index of microcirculatory dysfunction
- How many people
- 800 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 8 Apr 2016to 31 Dec 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The DIAST-CMD registry (Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function) is prospective registry which enrolled patients who underwent echocardiography, cnically-indicated invasive coronary angiography and comprehensive physiologic assessments including fractional flow reserve (FFR), CFR, and IMR measurements for at least 1 vessel from Samsung Medical Center. Patients with hemodynamic instability, severe LV dysfunction (left ventricular ejection fraction<40%), a culprit vessel of acute coronary syndrome, severe valvular stenosis or regurgitation were excluded.
Who may be able to join
- Patients who underwent clinically-indicated invasive coronary angiography
- Patients who underwent comprehensive physiologic assessments
- Patients who were evaluated by echocardiography
Who cannot join
- Patients with unavailable echocardiography data
- Patients with hemodynamic instability
- Patients with severe LV dysfunction (LV ejection fraction<30%)
- Patients with severe valvular stenosis or regurgitation
- Culprit vessel of acute coronary syndrome
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
South Korea3 sites
Chonnam National University Hospital
Gwangju
Chosun University Hospital
Gwangju
Samsung Medical Center
Seoul
United States1 site
University of Iowa Carver College of Medicine, Iowa City, IA, USA
Iowa City, Iowa
About this study
Official title: Prospective Registry Evaluating Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function
The DIAST-CMD registry (Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function) is prospective registry which enrolled patients who underwent echocardiography, cnically-indicated invasive coronary angiography and comprehensive physiologic assessments including fractional flow reserve (FFR), CFR, and IMR measurements for at least 1 vessel from Samsung Medical Center. Patients with hemodynamic instability, severe LV dysfunction (left ventricular ejection fraction<40%), a culprit vessel of acute coronary syndrome, severe valvular stenosis or regurgitation were excluded.
Read the detailed description
Cardiac diastolic dysfunction refers to a condition in which abnormalities in mechanical function are present during diastole and is an independent predictor of mortality, even in patients with preserved left ventricular (LV) systolic function. Clinical manifestations of cardiac diastolic dysfunction are also variable, from asymptomatic subclinical heart failure to heart failure with preserved ejection fraction, angina or exercise intolerance without significant epicardial coronary artery disease, or end-stage heart failure. Although its pathophysiology remains incompletely understood, findings from clinical and pre-clinical studies have suggested systemic endothelial dysfunction, oxidative stress, and coronary microvascular dysfunction (CMD) could be important pathophysiologic mechanisms for cardiac diastolic dysfunction.
In this regard, recent studies evaluated non-invasively measured coronary flow reserve (CFR) from positron emission tomography (PET), cardiac magnetic resonance imaging (MRI), or Doppler echocardiography, and presented the association of depressed global CFR with cardiac diastolic dysfunction and higher risk of clinical events. The presence of CMD can be also evaluated by invasive physiologic assessment using both CFR and index of microcirculatory resistance (IMR). Previous studies presented CMD could be one of the major causes of angina without significant epicardial coronary artery disease and an independent predictor of adverse clinical events in patients with stable ischemic heart disease, acute myocardial infarction (MI), or myocardial disease. Nevertheless, there has been limited study which evaluated the association between cardiac diastolic dysfunction and CMD using invasive physiologic indices and their prognostic implications, especially in non-MI patients without significant coronary artery stenosis.
Therefore, the current study was designed the current DIAST-CMD registry to evaluate 3 important clinical questions as to whether: (1) cardiac diastolic dysfunction is significantly associated with the presence of CMD; 2) both cardiac diastolic dysfunction and CMD are significantly associated with long-term cardiovascular death; and 3) integration of both disease entities would have incremental prognostic stratification in non-MI patients without significant epicardial coronary artery disease.
- Conditions
- Ischemic Heart Disease, Microvascular Coronary Artery Disease, Diastolic Dysfunction, Heart Failure With Preserved Ejection Fraction
- Being tested
- Echocardiography, Coronary flow reserve and index of microcirculatory dysfunction
- Keywords
- coronary microvascular dysfunction, diastolic dysfunction, coronary flow reserve, index of microcirculatory resistance, prognosis
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Echocardiographic grades of diastolic function was defined according to 2016 ASE/EACVI recommendations for the evaluation of LV diastolic function. Cardiac diastolic dysfunction was defined as elevated E/e'≥15.
Coronary flow reserve and index of microcirculatory dysfunctionDiagnostic test
Coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).
| Study group | Role | What they receive |
|---|---|---|
| Patients with cardiac diastolic dysfunction | Echocardiographic grades of diastolic function was defined according to 2016 ASE/EACVI recommendations for the evaluation of LV diastolic function. Cardiac diastolic dysfunction was defined as elevated E/e'≥15. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Coronary flow reserve and index of microcirculatory dysfunction | |
| Patients with coronary microcirculatory dysfunction | Patients with coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U). Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Coronary flow reserve and index of microcirculatory dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death
Cardiovascular death
Measured: 3 year
Secondary outcomes (5)
all-cause death
all-cause death
Measured: 3 year
Myocardial infarction
Myocardial infarction according to universal definition of MI
Measured: 3 year
Any revascularization
Any revascularization according to ARC definition
Measured: 3 year
Major adverse cardiac events
Major adverse cardiac events (MACEs, a composite of cardiovascular death, MI, and any revascularization)
Measured: 3 year
Heart failure admission
Admission due to heart failure
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start8 Apr 2016
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chonnam National University Hospital, Chosun University Hospital, Gangneung Asan Hospital
- Responsible party
- Principal investigator, Joo Myung Lee, Samsung Medical Center
- Investigators
- Joo Myung Lee, MD, MPH, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058833
- Sponsor's protocol ID
- SMCDIAST119023
- Acronym
- DIAST-CMD
- Status last verified
- Mar 2025
- First submitted
- 17 Sep 2021
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision of sharing IPD will be determined after discussion by executive committee of the current study.
Publications
Lee SH, Choi KH, Hong D, Shin D, Joh HS, Kim HK, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Prognostic Implications of Microvascular Resistance Reserve in Symptomatic Patients With Intermediate Coronary Stenosis. JACC Cardiovasc Interv. 2024 Mar 25;17(6):786-797. doi: 10.1016/j.jcin.2024.01.008.
PubMed 38538174Hong D, Shin D, Lee SH, Joh HS, Choi KH, Kim HK, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Prognostic Impact of Coronary Microvascular Dysfunction According to Different Patterns by Invasive Physiologic Indexes in Symptomatic Patients With Intermediate Coronary Stenosis. Circ Cardiovasc Interv. 2023 Mar;16(3):e012621. doi: 10.1161/CIRCINTERVENTIONS.122.012621. Epub 2023 Feb 27.
PubMed 36846961Hong D, Lee SH, Shin D, Choi KH, Kim HK, Ha SJ, Joh HS, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function on Cardiovascular Death. J Am Heart Assoc. 2023 Feb 7;12(3):e027690. doi: 10.1161/JAHA.122.027690. Epub 2023 Jan 25.
PubMed 36695307Chung YJ, Choi KH, Lee SH, Shin D, Hong D, Park S, Joh HS, Kim HK, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Prognostic Impact of Indeterminate Diastolic Function in Patients With Functionally Insignificant Coronary Stenosis. J Am Soc Echocardiogr. 2023 Mar;36(3):295-306.e5. doi: 10.1016/j.echo.2022.11.014. Epub 2022 Dec 5.
PubMed 36470507